NCT06312241

Brief Summary

The present study seeks to examine the feasibility, acceptance and efficacy of Metacognitive Training-Silver (MCT-Silver) BeWell among older adults (ages 60 years and older) delivered in a community setting (e.g., social-psychiatric community center, nursing homes, etc.).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

February 21, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

February 19, 2024

Last Update Submit

March 6, 2024

Conditions

Depressive SymptomsWell-Being, Psychological

Keywords

Metacognitive Traininginterventionolder adultscognitive-behavioral therapyMCT-Silver

Outcome Measures

Primary Outcomes (1)

  • Number of sessions attended

    The total number of sessions attended (of 10) will be used to assess the feasibility of the intervention

    10 weeks (pre (t0)- to post (t1))

Secondary Outcomes (10)

  • Participants' appraisal of the training

    after each session weeks 1 through 10; post (10 weeks; t1) and follow-up (3 months; t2)

  • Negative effects questionnaire (NEQ)

    post (10 weeks; t1) and follow-up (3 months; t2)

  • Depression (Beck Depression Inventory - II)

    baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)

  • Dysfunctional beliefs (18-item Dysfunctional Attitudes Scale)

    baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)

  • Mental Well-Being (Warwick-Edinburgh Mental Well-being Scale)

    baseline (t0), post (10 weeks; t1), and follow-up (3 months; t2)

  • +5 more secondary outcomes

Study Arms (1)

Metacognitive Training-Silver BeWell

EXPERIMENTAL

MCT-Silver BeWell is a cognitive-behavioral therapy based group intervention, which aims to improve insight for and change negative (meta)cognitive beliefs (e.g., negative mental filter), information-processing biases (e.g., mood-congruent memory), unhelpful behaviors (e.g., social withdrawal) and emotion-regulation (ER) strategies (e.g. rumination, avoidance of negative feelings) associated with the onset of depression. The training represents a variant of MCT-Silver for depression in later life developed for older adults without clinical depression.

Behavioral: Metacognitive Training-Silver BeWell

Interventions

Metacognitive Training-Silver BeWellBEHAVIORAL

Metacognitive Training- Silver BeWell is a cognitive behavioral based group intervention, which focuses on helping participants gain (metacognitive) distance from thought and behavioral patterns as well as behaviors and ER-strategies that are implicated in the onset of depression and reduced overall mental well-being. In 10 modules, MCT-Silver addresses issues specific to later life such as coping with physical changes and loss, as well as adapting to new (social) roles. The program also includes modules on identifying and re-defining values in later life, acceptance of negative feelings and resilience. In the training participants are made aware of information processing biases that have been shown to contribute to the onset of depression through engaging exercises using examples from daily life. Groups are comprised of up to 10 participants. Each session is 90 minutes.

Metacognitive Training-Silver BeWell

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent
  • Age 60 years or older
  • Sufficient command of the German language
  • Willingness to participate in intervention over a period of 10 weeks (participants who do not attend the intervention, but complete questionnaires will also be included in the analysis)
  • Visual and auditory acuity adequate for participation in group sessions
  • Ability to participate in the group setting (ability to participate in the group setting will be assessed during a screening interview (e.g., adequate social skills)).

You may not qualify if:

  • Acute suicidality as assessed by BDI-II Item 9
  • Dementia (MMSE \< 24) or evidence of severe organic brain dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Related Publications (11)

  • Moritz S, Menon M, Balzan R, Woodward TS. Metacognitive training for psychosis (MCT): past, present, and future. Eur Arch Psychiatry Clin Neurosci. 2023 Jun;273(4):811-817. doi: 10.1007/s00406-022-01394-9. Epub 2022 Mar 25.

    PMID: 35338378BACKGROUND

  • Miegel F, Rubel J, Dietrichkeit M, Hagemann-Goebel M, Yassari AH, Balzar A, Scheunemann J, Jelinek L. Exploring mechanisms of change in the metacognitive training for depression. Eur Arch Psychiatry Clin Neurosci. 2024 Apr;274(3):739-753. doi: 10.1007/s00406-023-01604-y. Epub 2023 Apr 17.

    PMID: 37067579BACKGROUND

  • Jelinek L, Hauschildt M, Wittekind CE, Schneider BC, Kriston L, Moritz S. Efficacy of Metacognitive Training for Depression: A Randomized Controlled Trial. Psychother Psychosom. 2016;85(4):231-4. doi: 10.1159/000443699. Epub 2016 May 27. No abstract available.

    PMID: 27230865BACKGROUND

  • Wu JJ, Wang HX, Yao W, Yan Z, Pei JJ. Late-life depression and the risk of dementia in 14 countries: a 10-year follow-up study from the Survey of Health, Ageing and Retirement in Europe. J Affect Disord. 2020 Sep 1;274:671-677. doi: 10.1016/j.jad.2020.05.059. Epub 2020 May 26.

    PMID: 32664001BACKGROUND

  • Yip PSF, Zheng Y, Wong C. Demographic and epidemiological decomposition analysis of global changes in suicide rates and numbers over the period 1990-2019. Inj Prev. 2022 Apr;28(2):117-124. doi: 10.1136/injuryprev-2021-044263. Epub 2021 Aug 16.

    PMID: 34400542BACKGROUND

  • Schaakxs R, Comijs HC, Lamers F, Kok RM, Beekman ATF, Penninx BWJH. Associations between age and the course of major depressive disorder: a 2-year longitudinal cohort study. Lancet Psychiatry. 2018 Jul;5(7):581-590. doi: 10.1016/S2215-0366(18)30166-4. Epub 2018 Jun 18.

    PMID: 29887519BACKGROUND

  • Reynolds CF 3rd, Jeste DV, Sachdev PS, Blazer DG. Mental health care for older adults: recent advances and new directions in clinical practice and research. World Psychiatry. 2022 Oct;21(3):336-363. doi: 10.1002/wps.20996.

    PMID: 36073714BACKGROUND

  • Schneider BC, Veckenstedt R, Karamatskos E, Ahlf-Schumacher J, Gehlenborg J, Schultz J, Moritz S, Jelinek L. Efficacy and moderators of metacognitive training for depression in older adults (MCT-Silver): A randomized controlled trial. J Affect Disord. 2024 Jan 15;345:320-334. doi: 10.1016/j.jad.2023.10.118. Epub 2023 Oct 19.

    PMID: 37865342BACKGROUND

  • Schneider BC, Bücker L, Riker S, Karamatskos E, Jelinek L. A pilot study of metacognitive training (D-MCT) for older adults with depression. Zeitschrift für Neuropsychologie. 2018; 29.

    BACKGROUND

  • Volz HP, Stirnweiss J, Kasper S, Moller HJ, Seifritz E. Subthreshold depression - concept, operationalisation and epidemiological data. A scoping review. Int J Psychiatry Clin Pract. 2023 Mar;27(1):92-106. doi: 10.1080/13651501.2022.2087530. Epub 2022 Jun 23.

    PMID: 35736807BACKGROUND

  • Hauschildt M, Arlt S, Moritz S, Yassari AH, Jelinek L. Efficacy of metacognitive training for depression as add-on intervention for patients with depression in acute intensive psychiatric inpatient care: A randomized controlled trial. Clin Psychol Psychother. 2022 Sep;29(5):1542-1555. doi: 10.1002/cpp.2733. Epub 2022 Mar 21.

    PMID: 35274407BACKGROUND

MeSH Terms

Conditions

DepressionPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • Brooke Viertel, PhD

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brooke Viertel, PhD

CONTACT

040 7410 24014b.viertel@uke.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2024

First Posted

March 15, 2024

Study Start

February 21, 2024

Primary Completion

August 1, 2025

Study Completion

December 1, 2025

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)